|Publication number||US7199995 B2|
|Application number||US 11/386,161|
|Publication date||Apr 3, 2007|
|Filing date||Mar 21, 2006|
|Priority date||Aug 15, 2005|
|Also published as||DE602006012400D1, EP1754511A2, EP1754511A3, EP1754511B1, US7035076, US20070035910|
|Publication number||11386161, 386161, US 7199995 B2, US 7199995B2, US-B2-7199995, US7199995 B2, US7199995B2|
|Inventors||Robert A. Stevenson|
|Original Assignee||Greatbatch-Sierra, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (11), Referenced by (68), Classifications (11), Legal Events (7)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This is a continuation of U.S. Ser. No. 11/161,730 filed Aug. 15, 2005, now U.S. Pat. No. 7,035,076.
The present invention relates generally to improved feedthrough terminal pin sub-assemblies and related methods of construction, particularly of the type used in active implantable medical devices, to decouple and shield undesirable electromagnetic interference (EMI) signals from the device. More particularly, the present invention relates to a reduced cost and reduced mechanical stress hermetic feedthrough terminal pin and ceramic feedthrough capacitor assembly which does not require an outer electrical connection between the one or more capacitors and a ground plane which is typically found in the form of a ferrule or device housing ground. It is adapted particularly for use in connecting one or more lead wires or conductive terminal pins through a hermetically sealed housing to internal electronic components of the medical device while decoupling EMI against entry into the sealed housing. The present invention is specifically designed for use in active implantable medical devices, such as cardiac pacemakers, implantable defribrillators, hearing implants, neuro-stimulators, drug pumps, bone growth stimulators, and the like.
Feedthrough terminal pin assemblies are generally well known in the art for connecting electrical signals through the housing or case of an electronic instrument. For example, in implantable medical devices such as cardiac pacemakers, defibrillators or the like, the terminal pin assembly comprises one or more conductive terminal pins supported by an insulator structure for feedthrough passage from the exterior to the interior of the medical device. Many different insulator structures and related mounting methods are known in the art for use in medical devices wherein the insulator structure also provides a hermetic seal to prevent entry of body fluids into the housing of the medical device. Said hermetic insulators for medical implant applications are typically constructed of alumina ceramic or glass wherein the terminal pins and ferrule are of suitable biocompatible material such as platinum, platinum-iridium, niobium, tantalum or titanium, respectively. However, the feedthrough terminal pins are typically connected to one or more exterior lead wires, for example, the leads which connect a cardiac pacemaker to the ventricle chamber of the heart, can also effectively act as an antenna and thus tend to collect stray EMI signals for transmission into the interior of the medical device. In many prior art devices, the hermetic terminal pin assembly has been combined directly with a ceramic feedthrough filter capacitor to decouple interference signals to the housing of the medical device.
In a typical unipolar construction, as described in U.S. Pat. No. 5,333,095 (the contents of which are incorporated herein), a coaxial ceramic feedthrough filter capacitor used in a feedthrough assembly to suppress and decouple undesired interference or noise transmission along a terminal pin comprises a so-called discoidal capacitor having two sets of electrode plates embedded in spaced relation within an insulative dielectric substrate or base, formed typically as a ceramic monolithic structure. One set of the electrode plates is electrically connected at an inner diameter cylindrical surface of the discoidal capacitor structure to the conductive terminal pin utilized to pass the desired electrical signal or signals. The other or second set of electrode plates is coupled at an outer diameter surface of the discoidal capacitor to a cylindrical ferrule of conductive material, wherein the ferrule is electrically connected in turn to the conductive housing of the electronic device. The number and dielectric thickness spacing of the electrode plate sets varies in accordance with the capacitance value and the voltage rating of the discoidal capacitor. In operation, the discoidal capacitor permits passage of relatively low frequency biological electrical signals along the terminal pin, while shielding and decoupling/attenuating undesired interference signals of typically high frequency to the conductive housing.
Feedthrough capacitors of this general type are available in unipolar (one), bipolar (two), tripolar (three), quadpolar (four), pentapolar (five), hexpolar (six) and additional lead configurations. The feedthrough capacitors of this general type are commonly employed in implantable cardiac pacemakers, defibrillators, and the like, wherein the pacemaker housing is constructed from a biocompatible metal, such as titanium alloy, which is electrically coupled to the second electrode plate set of the feedthrough filter capacitor. As a result, the filter capacitor and terminal pin assembly prevents entrance of interference signals to the interior of the pacemaker housing, wherein such interference signals could otherwise adversely affect the desired cardiac pacing or defibrillation function.
In the past, feedthrough filter capacitors for cardiac pacemakers and the like have typically been constructed by preassembly of the discoidal capacitor within a cylindrical or rectangular terminal pin subassembly which includes the conductive pin and ferrule. More specifically, the terminal pin subassembly is prefabricated to include one or more conductive terminal pins supported within the conductive ferrule by means of a hermetically sealed insulator ring or bead. See, for example, the subassemblies disclosed in U.S. Pat. Nos. 3,920,888; 4,152,540; 4,421,947; and 4,424,551. An improved design which has substantially improved the volumetric efficiency is based upon surface mounting of a ceramic feedthrough capacitor planar array structure to one outer surface of a hermetic terminal with similar connection to the conductive pins (see the subassemblies disclosed in U.S. Pat. No. 5,333,095). In all of the prior art described above, the outer feedthrough capacitor electrode plate sets are coupled in parallel together by a metallized layer which is either fired, sputtered or plated onto the ceramic capacitor. This metallized band, in turn, is coupled to the ferrule by conductive adhesive, soldering, brazing, or the like.
Although feedthrough filter capacitor assemblies of the type described above have performed in a generally satisfactory manner, the manufacture and installation of such filter capacitor assemblies has been relatively time consuming and therefore costly. For example, installation of the discoidal capacitor into the small annular space described by U.S. Pat. No. 4,424,551 between the terminal pin and ferrule can be a difficult and complex multi-step procedure to ensure formation of reliable, high quality electrical connections. The method taught by U.S. Pat. No. 4,424,551 (the contents of which are incorporated herein), teaches the injection of fluidic thermosetting conductive particles into first and second annular cavities (usually by centrifuge operations). As a consequence, this method also requires insulation of the interface between the capacitor structure and insulator, curing of the various thermosetting materials, and subsequent cleaning operations to remove excess conductive material. While the method taught by U.S. Pat. No. 5,333,095 is far simpler, a connection from the capacitor outside diameter and the conductive ferrule is still required.
A significant advance in the state of the art is described by internally grounded feedthrough capacitors as described in U.S. Pat. Nos. 5,905,627 and 6,529,103. These patents describe a methodology wherein it is not necessary to form a direct electrical connection between the outside diameter metallization of the feedthrough capacitor and the ferrule of the hermetic terminal of the implantable medical device. The internal ground technology teaches grounding of the second set of electrode pins through one or more grounded terminal pins. This has a significant advantage in that the elimination of the electrical and mechanical connection from the capacitor outside diameter or perimeter acts to significantly reduce the thermal and mechanical stress that is transmitted to the rather fragile feedthrough capacitor during the installation of the hermetic terminal pin assembly into the housing of the active implantable medical device by laser welding or the like. A significant number of EMI filtered hermetic terminals used in cardiac pacemakers and implantable defibrillators are manufactured using an internally grounded feedthrough capacitor. This has become a very popular and cost effective way of manufacturing such terminals. However, a significant cost driver is the need to provide one or more grounded pins for coupling to the second set of capacitor electrode plates. The present invention describes a novel method of providing internally grounded electrode plates within the hermetic terminal insulator itself. As will be further described herein, such internal ground plates within the insulator can be used to conveniently ground one or more terminal pins to couple to the second electrode plate set of the internally grounded capacitor.
A high integrity hermetic seal for medical implant applications is very critical to prevent the ingress of body fluids into the implanted device (e.g. pacemaker). Even a small leak rate of such body fluid penetration can, over a period of many years, cause moisture to build up and damage sensitive internal electronic components. This can cause catastrophic failure of the implanted device. The hermetic seal for medical implant applications is typically constructed of highly stable alumina ceramic or glass materials with very low bulk permeability.
Withstanding the high temperature and thermal stresses associated with the welding of a hermetically sealed terminal with a premounted ceramic feedthrough capacitor is very difficult to achieve with the prior art designs. The electrical/mechanical connection to the outside perimeter or outside diameter of the feedthrough capacitor has a very high thermal conductivity as compared to air. The hermetic bonding operation typically employed in the medical implant industry to install the filtered hermetic terminal into the implantable device housing generally involves a laser welding operation in very close proximity to this electrical/mechanical connection area. Accordingly, in the prior art, the ceramic feedthrough capacitor is subjected to a dramatic temperature rise. This temperature rise produces mechanical stress in the capacitor due to the mismatch in thermal coefficients of expansion of the surrounding materials. Many of these prior art devices employ a soldered connection to the outside perimeter or outside diameter of the feedthrough capacitor. Excessive installation soldering heat has been known to damage such devices.
The novel internally grounded feedthrough capacitors that are described by U.S. Pat. Nos. 5,905,627 and 6,529,103 solve these issues. By elimination of the outside diameter or outside perimeter electrical/mechanical connection area, the thermal and mechanical stresses are greatly reduced. That is, during laser welding of the titanium flange into the housing of the implantable medical device, said titanium flange will tend to expand and contract greatly. This transmits stresses to the rather sensitive monolithic ceramic feedthrough capacitor. Accordingly, elimination of said mechanical and electrical connection is a highly desirable feature. The present invention describes a very novel and convenient way of making connection to the second set of electrode plates without creating additional mechanical stresses.
A major market force within the medical implantable device industry has been to reduce the cost of the implanted device (e.g. pacemaker or implantable cardioverter defibrillator). Medical insurance carriers, government healthcare programs (e.g. Medicare) and health maintenance organizations (HMOs) are placing additional competitive pressures on the manufacturers of such devices.
Accordingly, there is a need for a novel feedthrough filter capacitor assembly that addresses the drawbacks noted above in connection with the prior art. In particular, a novel capacitor assembly is needed that is subjected to far less temperature rise during the manufacture thereof by eliminating an outside perimeter or outside diameter electrical/mechanical connection. Such a design would allow the use of much lower temperature materials (such as standard solder) to achieve the capacitor inside diameter lead connections. Moreover, such an improvement would make the assembly relatively immune to the aforementioned stressful installation techniques. A novel filter capacitor design is needed which is of simplified construction, utilizing a straightforward and uncomplicated feedthrough terminal pin subassembly that can result in manufacturing cost reductions. Of course the new design must be capable of effectively filtering out undesirable electromagnetic interference (EMI) signals from the target device. The present invention fulfills these needs and provides other related advantages.
The present invention resides in an improved internally grounded feedthrough filter capacitor assembly, wherein the capacitor assembly is subjected to far less temperature rise during the manufacture thereof by eliminating the outside perimeter or outer surface electrical/mechanical connection. The design of the present invention is capable of effectively filtering out undesirable EMI signals from the target device, while eliminating stressful installation techniques and resulting in size and manufacturing cost reductions.
The feedthrough filter capacitor assembly of the present invention generally comprises an internally grounded feedthrough filter capacitor having first and second electrode plates. A first passageway is formed through the capacitor through which a terminal pin extends in conductive relation with the first set of electrode plates. The terminal pin also extends through a conductive ground plane and an insulator in non-conductive relation. The insulator includes a ground plate conductively coupled to the ground plane. Means are provided for conductively coupling the capacitor second set of electrode plates and the insulator ground plates.
Typically, the ground plane comprises a ferrule which is conductively coupled to a housing for an active implantable medical device (AIMD), such as a cardiac pacemaker, an implantable defibrillator, a congestive heart failure device, a hearing implant, a cochlear implant, a neurostimulator, a drug pump, a ventricular assist device, an insulin pump, a spinal cord stimulator, an implantable sensing system, a deep brain stimulator, an artificial heart, an incontinence device, a vagus nerve stimulator, a bone growth stimulator, a gastric pacemaker, or a prosthetic device, or the housing for the AIMD itself.
The present invention, however, is not limited strictly to implantable medical devices. It also has broad application to military, space, external medical, telecommunications, and other applications. It will be obvious to those skilled in the art, that anytime that a hermetic seal is utilized to protect the internal electronic packaging, that the invention described herein provides significant advantages.
The insulator ground plate set typically extends to a conductive outer peripheral surface of the insulator, which is conductively coupled to the ground plane. In a particularly preferred embodiment, the insulator ground plate comprises a set of ground plates.
The coupling means, in a particularly preferred embodiment, includes a conductive material at least partially extending into a second passageway of the capacitor in conductive relation with the second set of electrode plates. The conductive material also at least partially extends through a second passageway of the insulator so as to be in conductive relation with the ground plates. Thus, any EMI is transferred from the conductive terminal pin to the first set of electrode plates, to the second set of electrode plates, and to the set of ground plates of the insulator (such as by the conductive material, and then to the ferrule and housing of the active implantable medical device. The conductive material may comprise one or more ground pins, a ground wire, a solder material, a conductive thermosetting material, a weld, a braze, a conductive glass, or a conductive spring coil such as that shown and described in U.S. patent application Ser. No. 10/907,361, filed Mar. 30, 2005.
Preferably, the outer peripheral surface of the capacitor is non-conductive and no conductive electrical/mechanical connection is made between it or the ferrule or active implantable medical device housing or the like.
The ground plates which are integral to the insulator structure of the hermetic terminal can be constructed of a number of materials. For example, if the insulator is alumina ceramic, the embedded ground electrode plates can be of the group of silver, palladium silver, platinum, platinum alloys and many other materials that are common in the art. Multi-layer alumina substrates, for example, are very common in circuit board or substrate manufacturing. It is also a novel feature of the present invention that said electrode plates could be made of ferro-magnetic materials. For example, the ground electrode plates could be made of nickel. This has desirable advantages to provide not just a convenient means of providing a grounded pin to the feedthrough capacitor, but also importantly provides magnetic shielding for the device. This could be particularly important in an MRI environment where it is necessary to prevent saturation of a ferrite inductor in the presence of a main static magnetic field of a magnetic resonance imaging machine.
The assembly of the present invention may also include an inductor, such as a ferrite inductor slab, through which the terminal pin extends in non-conductive relation. Preferably, the inductor is disposed adjacent to the capacitor. The inductor may be disposed between the capacitor and the insulator. The capacitor and insulator are preferably disposed in relation to each other, such as being adjacent to each other, but separated by a non-conductive material. In this regard, the disclosure of U.S. patent application Ser. No. 10/825,900 filed Apr. 15, 2004 is incorporated by reference herein.
Other features and advantages of the present invention will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention.
The accompanying drawings illustrate the invention. In such drawings:
As shown in the drawings, for purposes of illustration, the present invention is concerned with novel internally grounded feedthrough filter capacitor assemblies, generally designated in
Referring initially to
The feedthrough filter capacitor assembly 100 further includes an internally grounded feedthrough filter capacitor 110 that has first and second sets of electrode plates 112 and 114 (
In accordance with the present invention, the feedthrough filter capacitor 110 includes a monolithic, ceramic, internally grounded feedthrough filter capacitor having two or more (in this instance five) passageways extending therethrough. The outer four passageways are configured to receive therethrough the respective conductive terminal pins 102, and the internal diameter of the first passageways 116 are metallized (at 122) to form a conductive link between the first set of electrode plates 112 and the conductive terminal pins 102. A conductive polyimide fill, solder, or the like 124 is placed within the first passageways 116 between the metallization 122 and the respective terminal pin 102 to electrically link the terminal pin with the respective first set of electrode plates 112. As is well understood in the art, both sets of electrode plates 112, 114 are typically silk-screened onto ceramic plates, forming the feedthrough filter capacitor 110. These plates 112, 114 are surrounded by an insulative ceramic material that, for purposes of the present invention, need not be metallized on its exterior surfaces, as will be more fully discussed herein.
Similarly, the inner diameter of the central or second passageway 118 through the feedthrough filter capacitor 110 is also metallized (at 126) to conductively connect the second set of electrode plates 114, also referred to as the ground plates of the feedthrough filter capacitor 110. As discussed above, the second passageway 118 is configured to receive therethrough the conductive ground pin 120. Again, a conductive polyimide, solder or other conductive fill 128 is placed within the second passageway 118 between the ground pin 120 and the metallization 126 to conductively couple the ground pin 120 to the second set of electrode plates 114.
In typical applications in the prior art, the second set of ground electrodes 114 extend to the outer periphery of the capacitor 110. The outer surface of the capacitor 110 is then metalized by metallization firing or plating operations, or otherwise providing external conductive connections between capacitor 110 and a ground, typically the conductive ferrule 104. However, as discussed previously, in addition to requiring extra manufacturing steps, forming such conductive connections places a great deal of stress on the capacitor 110 during the manufacturing process and also presents drawbacks of the joining of materials which are not perfectly matched in thermal coefficient of expansion.
The present invention, as described herein, eliminates the need for such external conductive connections between the capacitor 110 and the ferrule 104, or other ground. Typically, the conductive ferrule 104 is conductively mounted to a conductive substrate that may comprise, for example, the housing for an active implantable medical device. The ground pin 120, which is electrically and conductively coupled to the second set of electrode plates 114, as discussed above, extends into the insulator 106 so as to be conductively coupled with the one or more ground plates 108 of the insulator 106. More particularly, as illustrated in
The ground plates 108, as shown in
Passageways 140 are also formed through the insulator 106, in general alignment with the capacitor passageways 116, for passage of the first conductive pins 102 therethrough. Due to the non-conductive nature of the material comprising insulator 106, the pins 102 could pass through in a frictional fit manner. However, in a particularly preferred embodiment, an upper beveled portion of the passageway 140 is metallized (at 142) such that a metal pre-form, such as gold or the like, or solder 144 can securely and hermetically connect the terminal pin 102 to the insulator 106. However, the metallization 142 does not come into contact with the one or more ground plates 108. Thus, the conductive pins 102 are electrically isolated from the ground plates 108 and the ferrule 104.
With continuing reference to
An optional inductor 144 may be associated with the capacitor 110, such as disposing the inductor 144 in between the capacitor 110 and the insulator 106, as illustrated in
As shown in
With reference now to
As described above, the ground pin 220 is in conductive relation with the second set of ground plates 214, such as by use of a conductive polyimide, solder or other conductive fill 228 disposed between the ground pin 220 and the inner-metallization 226 of the passageway through the capacitor 210. The conductive pins 202 are in conductive relation with the first set of electrode plates 212, such as by contact with metallization 222 of the passageway. However, the terminal pins 202 are electrically isolated from the ground plates 208 of the insulator 206, such as by the gold braze pre-form metallization 242 and gold braze connection 244. The ground pin 220, however, is conductively coupled with the ground plates 208 by either direct contact thereto or more typically via a conductive fill or solder 234 and an inner-metallization 232 which conductively couples the plates 208. Similar to that described above, the plates 208 extend to an outer surface metallization 236, which is conductively coupled to the ferrule 204 or other ground plane, such as by the conductive connection 238, which may comprise a pre-form. The outer surface metallization 236 of the insulator 206 can be formed by many techniques, including metal deposition techniques, including flame spray, electric arc, chemical plating and electro plating techniques, as well as silk screening and firing on a conductive glass frit matrix, conductive electrode ink or other metallic thick film.
With reference now to
With reference now to
Referring once again to
With reference now to
With reference now to
The significant advantage of the novel internally grounded feedthrough capacitor assemblies, as described herein, is that the mechanical (and electrical) connection to the outer surface of the capacitor is eliminated. In addition to eliminating manufacturing operations and reducing costs, this has the added effect of greatly reducing the mechanical stresses coupled to the relatively brittle ceramic capacitor structure caused by the mismatch in the thermal coefficient of expansion of the ceramic capacitor and the terminal or substrate to which it is mounted. This is particularly important for medical implant devices where the combined filter capacitor and hermetic terminal see high terminal stresses due to the requirement to weld such structure to the housing of a medical implant device. Thus, the capacitor structure is allowed to “float” in relative isolation from the surrounding materials. By elimination of the mechanical and electrical connection to the outside perimeter or outside diameter, the possibility of an adjunct or false hermetic seal is reduced or eliminated. Another benefit is that the penetration of the internal electrode plates to the external perimeter or outside diameter of the capacitor has been eliminated. This results in a more physically robust capacitor design with less tendency to delaminate along the knit line for internal electrode lamination layer. Accordingly, there would be less tendency for the capacitor to fracture, delaminate or otherwise structurally fail under thermal, mechanical or piezoelectric stresses. The only point of capacitor electrode penetration is the inside diameter of the cylindrical passageways for terminal pin connection. This tends to make the feedthrough capacitor a more solid, monolithic structure which is more resistant to moisture or solvent penetration. As the brittle ceramic capacitor is isolated from the ferrule, the capacitor is much more resistant to damage during ferrule installation by soldering, pressing, or screw-in torque. The capacitor, being isolated from the case or ferrule, makes it much more resistant to gripping tools which are used by the customer during installation.
As previously mentioned, internally grounded feedthrough capacitors are known in the art and described by U.S. Pat. Nos. 5,905,627 and 6,529,103. These two patents describe internally grounded capacitors with various means for connecting the capacitor's second set (or ground electrode set) of electrodes to a terminal pin which is part of the ferrule. The significant advantage of the novel internally grounded hermetic insulator is that this eliminates the need for one or more conductive terminal pins to be brazed or welded into the ferrule itself. This is particularly important for cylindrical EMI filter hermetic terminal assemblies. The reason for this is it is quite difficult to extend a web plate across the ferrule to the center of the capacitor. It is far better to have an insulative structure between the capacitor or inductor and the alumina insulator structure 106. The present invention eliminates the need for a web plate and welded terminal pin which is, effectively, all part of the ferrule. The present invention also provides a high degree of volumetric efficiency in that by elimination of the web plate there is no need to increase the overall height of the EMI filter terminal assembly. Referring once again to
Although several embodiments of the invention have been described in detail for purposes of illustration, various modifications of each may be made without departing from the spirit and scope of the invention. Accordingly, the invention is not to be limited, except as by the appended claims.
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|U.S. Classification||361/302, 607/5, 361/307, 361/306.2|
|International Classification||H01G4/228, H01G4/35, H01G4/236|
|Cooperative Classification||H01G4/35, A61N1/3754|
|European Classification||A61N1/375A2, H01G4/35|
|Mar 21, 2006||AS||Assignment|
Owner name: GREATBATCH-SIERRA, INC., NEVADA
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Effective date: 20050809
|Apr 9, 2007||AS||Assignment|
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|Nov 22, 2007||AS||Assignment|
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